TrackTrace Rx

Month: August 2017

The Innovative Abilities Of Blockchain In Meeting DSCSA

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There’s been a great deal of recent interest in the use of Blockchain technology to tackle challenges in the healthcare field, especially when it comes to maintaining compliance with the DSCSA. Beginning in November of 2023, pharmaceutical supply companies will be required to maintain accurate information that will let drugs be traced along the supply chain. The pharmaceutical industry has a huge challenge ahead of it to meet these standards, and Blockchain technology may be one of the solutions.

To understand whether or not Blockchain represents a valid solution to the issue of supply chain tracking, some background on it is necessary.

What Is Blockchain?

Blockchain technology is essentially a method of encapsulating data or information within a layered data structure so that multiple parties can trust in the accuracy of the source of information. You can think of it like a digital ledger that tracks transactions and lets multiple parties see those transactions, with an added layer of security.

The most famous use of Blockchain is to track the transactions of cryptocurrencies like Bitcoin, but it has applications for the healthcare field including anti-counterfeiting and supply chain regulatory compliance.

How Can Blockchain Be Used To Assist In DSCSA Compliance?

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After November 27, 2023, US companies in the pharmaceutical supply chain will no longer have to give transaction histories to their customers, instead they will have to retain “…systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer”.

Gathering all the documents related to transaction information would be necessary only when there is an investigation into possibly illegitimate products. This poses a problem under the new system, as many questions will be raised regarding the authenticity of the party asking for the transaction information.

If a hospital needs to gather transaction information for a drug going all the way back to the manufacturer, you can easily imagine the manufacturer asking a series of questions to see if the hospital can be trusted.

“Do you actually own the drug you’re asking for info about?” “Are you actually a trusted member of the supply chain?”

Considering what is at stake for the manufacturer, it makes sense that they would not respond to people asking for this information unless they can prove that they are trustworthy. This is a time intensive and frustrating process, and the law allows only so much time to provide the required transaction information.

This is where Blockchain comes in as a possible solution to this problem. Blockchain introduces a way of ensuring that the party making a request for information can be trusted, that their reason for requesting the information is legitimate, and that they own the product they are asking about.

Let’s take a closer look at the key features of Blockchain and the difficulties in implementing the DSCSA.

Why Is Blockchain So Helpful In Meeting DSCSA Challenges?

The Center for Supply Chain Studies (C4SCS) is an organization created to assist different industries in evaluating the impact of changes in regulatory, business, or technological areas. A team from the C4SCS conducted an in-depth investigation of the challenges in industry compliance with the new DSCSA standards, and if Blockchain could assist in solving these issues.

Here’s a rundown on the challenges of meeting compliance for DSCSA, as identified by the C4SCS:

  • There’s a distributed environment with a wide variety of companies and parties in the industry
  • There’s a need to share data with unknown participants in the supply chain
  • A massive amount of data exists to be collected and stored
  • Current proposed solutions to DSCSA compliance are expensive and intrusive, largely relying on adequate funding and governance to ensure compliance

And here are some of the key features of Blockchain that make it attractive:

  • Blockchain is distributed, with no central authority
  • Blockchain is also anonymous, and anyone can participate in it at any time
  • There’s a single point of entry involved in Blockchain, which makes connection easy. It’s also private, and you don’t need everyone to know when you’ve entered Blockchain
  • It’s safe and trustworthy
  • Blockchain is self-funded, it generates income for the parties which perform the services necessary

It’s easy to see that the features of Blockchain align nicely with the DSCSA and provide possible solutions to its issues. The problem of a distributed environment is handled by the fact that Blockchain itself is also distributed, yet secure and trustworthy. Blockchain gives people a way of trusting other parties without needing a central repository or governing agency to oversee everything and would work whether or not a distributed or centralized architecture was used.

Blockchain’s Adoption Problems

The C4SCS team is convinced that Blockchain represents a viable solution to the problems posed by the new DSCSA standards. However, there are issues preventing widespread adoption of Blockchain.

Blockchain is still a rather new technology and lacks the technical standards that would encourage wide acceptance of the platform. For this reason, many industry observers feel that it is still too early to pursue commercial applications for Blockchain. That said, there is an intense interest and energy around Blockchain that will spur further development of the technology and of its standards, so it is possible that by 2023 the technology will have advanced far enough to make Blockchain the obvious solution to the DSCSA’s compliance issues.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

 

Will You Be Affected by the DSCSA?

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The Drug Supply Chain Security Act (DSCSA) was signed back in 2013 and aims to give the Federal Drug Administration (FDA) more power to regulate drugs and protect patients from counterfeit, contaminated, or otherwise dangerous drugs.

The World Health Organization (WHO) says that between 1% and 10% of all medical drugs sold throughout the world are counterfeit, and some countries have a counterfeit rate as high as 50%. To combat this problem and protect patients of these drugs, manufacturers, distributors, repackagers, and dispensers will be required to comply with the provisions of the act, which include providing transaction information on sales of certain prescription drugs

Which companies will be impacted by the DSCSA?

How do you know if your company will be affected?

It would be tempting to say that any company that handles pharmaceutical-grade drugs must abide by DSCSA regulations, but in practice, it’s more difficult to get an exact answer. There are exemptions to the requirements for certain products and transactions, however, and state laws regarding the handling of certain drugs may conflict with how the DSCSA classifies them.

As a general rule of thumb, if a company is a defined by the act as a trading partner, and it deals in prescription drugs not exempted from DSCSA regulations, it’s probably under the jurisdiction of the DSCSA.

Defining Prescription Drugs and Exemptions

It’s important to understand what classifies as a prescription drug under the DSCSA. Section 503(b)(1) of the Food, Drug, and Cosmetics Act defines a “prescription drug” as a drug intended for human use and the DSCSA says the drug must be in “finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution).”

In general, over-the-counter drugs, medical devices, and drugs for animals are exempt from the act. Drugs which require a pharmacist to dispense it typically fall under the act, but not always. While a drug may require a pharmacist to dispense it, that doesn’t mean the FDA classifies it as a prescription drug, since state laws might require certain drugs to be handled by a pharmacist though the FDA doesn’t classify it as a prescription drug.

Other products exempted from DSCSA regulations include:

  • Blood for transfusions
  • Radioactive drugs or radioactive biological products
  • Medical gases
  • Compounded drugs
  • Imaging drugs
  • Intravenous products intended to replenish fluids or electrolytes
  • Drugs intended for irrigation or sterile water

Defining Trading Partners

Let’s go back to trading partners. How are trading partners defined under the DSCSA?

A trading partner is any company, organization, or entity such as a dispenser, manufacturer, repackager, logistics provider, or wholesaler distributor.

A dispenser is defined as any hospital, retailer, pharmacy, or group of pharmacies under common ownership and control (which don’t act as a wholesaler distributor), or any other person who is authorized to administer or dispense prescription drugs. The associated warehouses or distribution centers of authorized people or groups (which don’t act as a wholesale distributor) are also impacted by the regulations.

Manufacturers are classified as a person who has an approved application under Section 505 or a license issued to them under Section 351 of the Public Health Service Act.

A repackager is a company that relabels and repackages drugs for distribution or sale, including repackaging departments, which are actually a part of most hospitals.

Wholesale distributors are groups who are involved in the wholesale distribution of a prescription drug to any person or group other than the patient. This doesn’t include manufacturers, third-party logistics providers, or repackagers.

A third-party logistics provider refers to an entity that provides logistical support for a drug for other organizations, but does not own the product. The other mentioned categories take direct ownership of the drug.

Transaction Exemptions

So a company must adhere to DSCSA regulations if they’re classified as a trading partner and dealing with prescription drugs, right? Is that all there is to it? Unfortunately no, it’s a bit more complicated than that. As it turns out even if a particular drug is not exempt, a company may still be exempt from many DSCSA provisions when it’s conducting certain kinds of transactions. To put that another way, a product would need to follow the DSCSA under other transactions, but in these specific transactions, they do not.

The list of exempt transactions include:

  • Intra-company distribution of products within a single manufacturer, or between members of an affiliate.
  • Distribution of samples of a product by a licensed wholesale distributor or manufacturer
  • Distribution of “medical convenience kits”, collections of finished medical devices which might include drug products or biological products and are packaged in kits for the convenience of the user, if:
  • The kit is assembled in an establishment registered by the FDA as a device manufacturer, the kit doesn’t contain a controlled substance, and the manufacturer of the kit purchased the product contained in the kit directly from the manufacturer or from a wholesale distributor that purchased it directly from the manufacturer.
  • The label on the primary container of the drug or biologic product in the kit is not altered and the product in the kit is one of the following:
    • A vasopressor, a sympathomimetic, an anesthetic, an anticoagulant, an intravenous solution intended for the replenishment of fluids and electrolytes, a product intended to maintain the equilibrium of water and minerals in the body, or a product intended for irrigation or reconstitution.

The upcoming DSCSA deadline is November 27, 2017, and it will require manufacturers to label each product with a unique product identifier. While it was rumored that DSCSA enforcement has been delayed, in reality, the law has not been delayed. The FDA will merely be exercising discretion and giving companies a little more leeway when it comes to penalties for non-compliance.

The list of DSCSA provisions and exemptions requires close reading because in the end, you are the only person who can decide if your company and product falls under the act. Only with a careful reading of the provisions and an intimate knowledge of your product can you arrive at that crucial decision.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

3 Things About Serialization Planning You Need to Know

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Even though compliance is the primary reason most pharma companies are implementing serialization, there is a wealth of business value beyond it. DSCSA compliance opens a window of opportunities for businesses, and forward-thinking leaders are exploring them now.

As of November 2017, prescription drugs sold on the US market must be serialized. This means pharma companies must have an operational serialization solution by that time. By 2023, the industry must enable data exchange and full unit-level traceability.

The Drug Supply Chain Security Act creates significant roadblocks for businesses, as it takes a large-scale strategy to reach full compliance. Planning, implementation, mitigating disruptions across the enterprise and the pharmaceutical supply chain are just the formal tip of the iceberg. Below, there is the significant investment in a myriad of solutions and adjustments. From software and hardware to staff training, and development of new processes that ensure compliant reporting, and serialization.

#1. Capturing Data

Even though DSCSA-mandated labeling and reporting requirements are top of mind, there are opportunities pharma companies can explore to optimize processes and boost revenue. Assessing short-term compliance goals and long-term ones such as scalability, rich data, and its value for business intelligence can drive substantial business value.

The captured data holds the key to the future value generation that goes beyond DSCSA compliance and reporting to your partners in the supply chain. You can use it to support an investigation in case the supply chain gets compromised. You can tap into it to simplify processing of ad-hoc queries, and to support your routine operations. You can use it to analyze which lines perform the best, and replicate those efficiencies across the operations.

The data about a product’s critical tracking events is money – you just have to convert it into efficiencies, and improvements. That said, consider capturing the data in the full format. The serial numbers, the date and time complete with the time zone, the location, and the business context. The latter can include any relevant details, such as product condition, or associated transactions.

Beyond the DSCSA-mandated commissioning, packing, and shipping, consider capturing sampling, inspection, exception processing, reverse logistics, unpacking, and repacking. In other words, consider where you could benefit from greater visibility into the processes.

#2. Providing Data

Drug manufacturers, distributors, contract manufacturers, third-party logistics providers and repackagers – all must contribute their share to ensuring the products they operate are traceable. Each one of the trading partners expects to receive tracking events data from the manufacturers, which in its turn needs data from a supplier.

So, the goal here is to have a clear idea of what data each partner needs. The roadblock could be that not all of your partners may have a good idea of their data requirements. Regardless, make sure to get the details that will save you a headache in the future. You may want to inquire with your partners about:

  • The critical tracking-event data they need – ensure you capture it; if not, adjust accordingly.
  • The master data they need you to sync with their systems – item attributes such as name, dose, and dosage form, required party, location, etc.
  • Shared use of the same identifiers for product identification and party/location identification– i.e. SGTIN, GLN.

#3. Interoperability

Providing your partners with the right data, and receiving the data you need, is by far not the only focus area you need to clear with your trading partners. Technical issues usually tend to be the most expensive to troubleshoot, and interoperability of your solution and your partners’ solution is paramount. With the deadline impending, there is little time left to test and ensure your IT systems and those of your partners can inter-operate reliably when DSCSA prime time comes.

When you need to interface with multiple partners, there must be a consistent acceptance of industry standards in some critical aspects, such as:

  • The format of data your partners will send and expect to receive (GS1 EPCIS and the GS1 US guideline for EPCIS).
  • The data exchange mechanism your partners intend to use and their security requirements (Secure File Transfer Protocol, Applicability Statement 2), their advantages and disadvantages for your operations.

Choosing Vendors

Determining vendor evaluation criteria is key to addressing your business requirements. For example, will the vendor ensure to provide the right data based on your business processes, and if yes, have they done so for other companies? Does the vendor comply with the GS1 US guideline for the use of EPCIS in the US drug supply chain?

Now that everyone is pressed for time with their serialization implementation, you need to ensure the vendor has sufficient resources (support, technical, engineering capacity) to cater to your specific needs adequately. In other words, are their resources stretched thin? Of note is whether the vendor is already working with any of your trading partners, and the interoperability level they can ensure.

Final Words

The right serialization and traceability solution offers a wealth of benefits beyond DSCSA compliance. According to a recent KPMG survey, more than 70% of polled companies “plan to use serialization data to enhance business processes.”

While companies are investing tens and even hundreds of millions of dollars to reach end-to-end traceability of drugs within the US supply chain by 2023, it makes all the sense to focus on the long-term value potential of all their implemented solutions.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza